A Phase 2a Double Blind, Placebo Within-Patient Controlled, Multi-Center Dose Ranging Study to Evaluate the Safety and Preliminary Efficacy of AZX100 Drug Product in Trocar Sites of Arthroscopic Shoulder Surgery Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 5
- 主要终点
- Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores
研究概览
简要总结
The purpose of this study was to determine the safety of AZX100 Drug Product and to determine whether it was effective in preventing or reducing scars that were made from trocars following arthroscopic shoulder surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for an arthroscopic shoulder surgery that will result in at least 3 trocar sites
- •Healthy male or non-pregnant female 18-75 years old
- •Non-diabetic
- •Body Mass Index 18-35
- •No clinically significant abnormal values on blood test
- •Non-smoker for previous 6 months
排除标准
- •History of acute or chronic disease
- •Cancer within previous 5 years, except for removed skin cancer
- •Hypersensitivity reaction
- •Allergy to general anesthesia, lidocaine, or epinephrine
- •Current skin disorder other than folliculitis or acne
- •On therapy with steroids
- •On therapy with a drug that affects collagen synthesis
- •Positive for HIV or hepatitis
- •Positive urine test for nicotine
- •Positive blood test for anti-AZX100 antibodies
- •Participated in another clinical study within 60 days before enrollment
- •Gave blood within 7 days before dosing
- •Gave plasma within 3 days before dosing
- •Tattoo on the shoulder area
- •Applied any prescribed or over the counter agents to the shoulder within 14 days before dosing, or intend to use any scar improving product
- •Visited a tanning salon within 14 days before dosing
- •History of drug addiction or excessive use of alcohol
研究组 & 干预措施
AZX100-placebo
Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive one low dose of AZX100 3 mg/linear cm, one high dose of AZX100 10 mg/linear cm, or placebo (saline).
干预措施: Placebo (Drug)
AZX100-placebo
Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive one low dose of AZX100 3 mg/linear cm, one high dose of AZX100 10 mg/linear cm, or placebo (saline).
干预措施: AZX100 (Drug)
Placebo-only
Three trocar sites on each patient received one dose of placebo (saline).
干预措施: Placebo (Drug)
结局指标
主要结局
Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores
时间窗: 12 months
Efficacy was based on the difference between mean POSAS scores of placebo and 3 mg AZX100, and placebo and 10 mg AZX100 12 months after shoulder surgery. Three trocar sites were randomized on each patient to receive AZX100 3 mg or AZX100 10 mg or placebo at 9 days and 21 days after shoulder surgery. PSAS results included patients' ratings on a scale of 1-10 (1 was normal skin or no complaints and 10 was the worst imaginable scar or the worst difference) for the following: Is the scar painful? Is the scar itching? Is the color of the scar different? Is the scar more stiff? Is the thickness of the scar different? Is the scar irregular? The possible minimum score was 6 and the maximum (worst) score was 60. OSAS results included observers' ratings on a scale of 1-10 (1 was normal skin and 10 was the worst scar imaginable) for vascularization, pigmentation, thickness, relief, and pliability. The possible minimum score was 5 and the possible maximum (worst) score was 50.
次要结局
- Between-group Mean Differences in Visual Analog Scale Scores Rated by Independent Blinded Raters Using 3D Photography(12 months)
- Between-group Mean Differences in Objective Measures Via 3D Photography (Elevation, Length, Width)(12 months)
- Between-group Mean Differences in Objective Measures Via 3D Photography (Volume)(12 months)
- Histological Evaluation of Collagen(12 months)
- Histological Evaluation of Number of Alpha Smooth Muscle Actin Cells(12 months)